La. Admin. Code tit. 33 § XV-605

Current through Register Vol. 50, No. 11, November 20, 2024

Section XV-605 - Fluoroscopic X-Ray Systems

A. Only image-intensified or direct digital receptor fluoroscopic equipment shall be used for fluoroscopy.

1. Primary Protective Barrier

a. The fluoroscopic imaging assembly shall be provided with a primary protective barrier that intercepts the entire cross section of the useful beam at any SID.

b. The X-ray tube used for fluoroscopy shall not produce X-rays unless the primary protective barrier is in position to intercept the entire useful beam.

2. Field Limitation

a. Neither the length nor the width of the X-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3 percent of the SID. The sum of the excess length and the excess width shall be no greater than 4 percent of the SID. In addition, the following requirements apply:

i. a means shall be provided to permit further limitation of the field. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID and/or a visible area of greater than 300 square centimeters shall be provided with means for stepless adjustment of the X-ray field;

ii. all equipment with a fixed SID and a visible area of 300 square centimeters or less shall be provided with either stepless adjustment of the X-ray field or with means to further limit the X-ray field size at the plane of the image receptor to 125 square centimeters or less. Stepless adjustment shall provide continuous field sizes from the maximum obtainable to a field size of 5 centimeters by 5 centimeters or less;

iii. for equipment manufactured after February 25, 1978, when the angle between the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor; and

iv. compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor. For rectangular X-ray fields used with circular image reception, the error in alignment shall be determined along the length and width dimensions of the X-ray field that pass through the center of the visible area of the image receptor.

b. Spot-film devices shall meet the following additional requirements:

i. means shall be provided between the source and the patient for adjustment of the X-ray field size in the plane of the image receptor to the size of that portion of the image receptor that has been selected on the spot film selector. Such adjustment shall be automatically accomplished when the X-ray field size in the plane of the image receptor is greater than that of the selected portion of the image receptor. If the X-ray field size is less than that of the selected portion of the image receptor, the field size shall not open automatically to the size of the selected portion of the image receptor unless the operator has selected that mode of operation;

ii. it shall be possible to adjust the X-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor. The minimum field size at the greatest SID shall be equal to, or less than, 5 centimeters by 5 centimeters;

iii. the center of the X-ray field in the plane of the image receptor shall be aligned with the center of the selected portion of the image receptor to within 2 percent of the SID; and

iv. means shall be provided to reduce the X-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor such that:

(a). for spot-film devices used on fixed-SID fluoroscopic systems which are not required to, and do not provide stepless adjustment of the X-ray field, the minimum field size, at the greatest SID, does not exceed 125 square cm; or

(b). for spot-film devices used on fluoroscopic systems that have a variable SID and/or stepless adjustment of the field size, the minimum field size, at the greatest SID, shall be containable in a square of 5 cm by 5 cm.

c. A capability may be provided for overriding the automatic X-ray field size adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic X-ray field size adjustment override is engaged. Each such system failure override switch shall be clearly labeled as follows:

FOR X-RAY FIELD LIMITATION SYSTEM FAILURE.

d. On spot-film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the X-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.

e. Fluoroscopy and Radiography Using the Fluoroscopic Imaging Assembly with Inherently Circular Image Receptors

i. For fluoroscopic equipment manufactured before June 10, 2006, other than radiation therapy simulation systems, the following applies:

(a). neither the length nor width of the X-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3 percent of the SID. The sum of the excess length and the excess width shall be no greater than 4 percent of the SID; and

(b). for rectangular X-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the X-ray field which pass through the center of the visible area of the image receptor.

ii. For fluoroscopic equipment manufactured on or after June 10, 2006, other than radiation simulation systems, the maximum area of the X-ray field in the plane of the image receptor shall conform with one of the following requirements:

(a). when any linear dimension of the visible area of the image receptor measured through the center of the visible area is less than or equal to 34 cm in any direction, at least 80 percent of the area of the X-ray field overlaps the visible area of the image receptor; or

(b). when any linear dimension of the visible area of the image receptor measured through the center of the visible area is greater than 34 cm in any direction, the X-ray field measured along the direction of greatest misalignment with the visible area of the image receptor does not extend beyond the edge of the visible area of the image receptor by more than 2 cm.

f. Fluoroscopy and Radiography Using Fluoroscopic Imaging Assembly with Inherently Rectangular Image Receptors

i. For X-ray systems manufactured on or after June 10, 2006, the following applies:

(a). neither the length nor width of the X-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3 percent of the SID. The sum of the excess length and the excess width shall be no greater than 4 percent of the SID; and

(b). the error in alignment shall be determined along the length and width dimensions of the X-ray field which pass through the center of the visible area of the image receptor.

g. Override Capability. If the fluoroscopic X-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided for overriding the automatic adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic field adjustment is overridden. Each such system failure override switch shall be clearly labeled as follows:

FOR X-RAY FIELD LIMITATION SYSTEM FAILURE.

3. Activation of the Fluoroscopic Tube. X-ray production in the fluoroscopic mode shall be controlled by a device that requires continuous pressure by the operator for the entire time of any exposure. When recording serial fluoroscopic images, the operator shall be able to terminate the X-ray exposure(s) at any time, but means shall be provided to permit completion of any single exposure of the series in process.

4. Air Kerma Rates (AKR)

a. Fluoroscopic Equipment Manufactured Before May 19, 1995

i. Fluoroscopic equipment provided with automatic exposure rate control (AERC) shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) at the measurement point specified in LAC 33:XV.605.A.4.d, except as specified in LAC 33:XV.605.A.4.a.v.

ii. Equipment provided without AERC shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 44 mGy per minute (vice 5 R/min exposure rate) at the measurement point specified in LAC 33:XV.605.A.4.d, except as specified in LAC 33:XV.605.A.4.a.v.

iii. Equipment provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) in either mode at the measurement point specified in LAC 33:XV.605.A.4.d, except as specified in LAC 33:XV.605.A.4.a.v.

iv. Equipment may be modified in accordance with this Section to comply with LAC 33:XV.605.A.4.b. When the equipment is modified, it shall bear a label indicating the date of the modification and the statement:

MODIFIED TO COMPLY WITH LAC 33:XV.605.

v. Exceptions: during recording of fluoroscopic images.

b. Fluoroscopic Equipment Manufactured on or after May 19, 1995

i. Equipment shall be equipped with AERC if operable at any combination of tube potential and current that results in an AKR greater than 44 mGy per minute (vice 5 R/min exposure rate) at the measurement point specified in LAC 33:XV.605.A.4.d. Provision for manual selection of technique factors may be provided.

ii. Equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 88 mGy per minute (vice 10 R/min exposure rate) at the measurement point specified in LAC 33:XV.605.A.4.d, except as specified in LAC 33:XV.605.A.4.b.iii.

iii. Exceptions:

(a). for equipment manufactured prior to June 10, 2006, during the recording of images from a fluoroscopic image receptor using photographic film or a video camera when the X-ray source is operated in a pulsed mode; or

(b). for equipment manufactured on or after June 10, 2006, during the recording of images from the fluoroscopic image receptor for the purpose of providing the user with a recorded image(s) after termination of the exposure. Such recording does not include images resulting from a last-image-hold feature that are not recorded.

c. When optional high level control is selected and the control is activated, the equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of 176 mGy per minute (vice 20 R/min exposure rate) at the measurement point specified in LAC 33:XV.605.A.4.d. Special means of activation of high level control shall be required. The high level control shall only be operable when continuous manual activation is provided by the operator. A continuous signal audible to the operator shall indicate that the high level control is being employed.

d. Compliance with the requirements of LAC 33:XV.605.A.4 shall be determined as follows:

i. if the source is below the X-ray table, the AKR shall be measured 1 centimeter above the tabletop or cradle;

ii. if the source is above the X-ray table, the AKR shall be measured at 30 centimeters above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement;

iii. in a C-arm or L-U arm type of fluoroscope, the AKR shall be measured 30 centimeters from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than 30 centimeters from the input surface of the fluoroscopic imaging assembly;

iv. in a C-arm type fluoroscope having an SID less than 45 cm, the AKR shall be measured at the minimum SSD; and

v. in a lateral type fluoroscope, the AKR shall be measured at a point 15 centimeters from the centerline of the X-ray table and in the direction of the X-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral X-ray source, with the end of the beam-limiting device or spacer no closer than 15 centimeters to the center line of the X-ray table.

5. Barrier Transmitted Radiation Rate Limits

a. The AKR due to transmission through the primary protective barrier with the attenuation block in the useful beam, combined with radiation from the image intensifier, shall not exceed 3.34X10^-3 percent of the entrance AKR at 10 centimeters from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor. Radiation therapy simulation systems shall be exempt from this requirement provided the systems are intended only for remote control operation.

b. Measuring Compliance of Barrier Transmission

i. The AKR due to transmission through the primary protective barrier combined with radiation from the image intensifier shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

ii. If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned 30 centimeters above the tabletop.

iii. If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than 30 centimeters.

iv. Movable grids and compression devices shall be removed from the useful beam during the measurement.

v. For all measurements, the attenuation block shall be positioned in the useful beam 10 cm from the point of measurement of entrance AKR and between this point and the input surface of the fluoroscopic imaging assembly.

6. Indication of Potential and Current. During fluoroscopy and cinefluorography the kV and the mA shall be continuously indicated.

7. Source-to-Skin Distance. The SSD shall not be less than:

a. 38 centimeters on stationary fluoroscopic systems;

b. 30 centimeters on all mobile fluoroscopes; and

c. 20 centimeters for fluoroscopes intended for specific surgical or interventional applications that would be prohibited at the source-to-skin distances specified in this Paragraph. Provisions shall be made for operating at shorter source-to-skin distances.

d. For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after June 10, 2006, having a maximum source-to-image receptor distance of less than 45 cm, means shall be provided to limit the source-to-skin distance to not less than 19 cm. Such systems shall be labeled for extremity use only. In addition, for those systems intended for specific surgical applications that would be prohibited at the source-to-skin distance specified in this Paragraph, provisions shall be made for operation at shorter source-to-skin distances, but not less than 10 cm.

8. Fluoroscopic Irradiation Time, Display, and Signal

a. Fluoroscopic equipment manufactured before June 10, 2006:

i. shall be provided with means to preset the cumulative irradiation time of the fluoroscopic tube. The maximum cumulative time of the timing device shall not exceed five minutes without resetting. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative irradiation time. Such signal shall continue to sound while X-rays are produced until the timing device is reset. Fluoroscopic equipment shall be modified in accordance with LAC 33:XV.605 to comply with the requirements of this Paragraph. When the equipment is modified, it shall bear a label indicating the statement; or

MODIFIED TO COMPLY WITH LAC 33:XV.605

ii. as an alternative to the requirements of this Paragraph, radiation therapy simulation systems shall be provided with a means to indicate the total cumulative exposure time during which X-rays were produced, and which is capable of being reset between X-ray examinations.

b. For X-ray controls manufactured on or after June 10, 2006, there shall be provided for each fluoroscopic tube:

i. a display of the fluoroscopic irradiation time at the fluoroscopist's working position. This display shall function independently of the audible signal described in this Subparagraph. The following requirements apply:

(a). when the X-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes shall be continuously displayed and updated at least once every six seconds;

(b). the fluoroscopic irradiation time shall also be displayed within six seconds of termination of an exposure and remain displayed until reset; and

(c). means shall be provided to reset the display to zero prior to the beginning of a new examination or procedure;

ii. a signal audible to the fluoroscopist shall sound for each passage of five minutes of fluoroscopic irradiation time during an examination or procedure. The signal shall sound until manually reset or, if automatically reset, for at least two seconds.

9. Display of Last-Image-Hold (LIH). Fluoroscopic equipment manufactured on or after June 10, 2006, shall be equipped with means to display LIH image following termination of the fluoroscopic exposure.

a. For an LIH image obtained by retaining pretermination fluoroscopic images, if the number of images and method of combining images are selectable by the user, the selection shall be indicated prior to the initiation of the fluoroscopic exposure.

b. For an LIH image obtained by initiating a separate radiographic-like exposure at the termination of fluoroscopic imaging, the technique factors for the LIH image shall be selectable prior to the fluoroscopic exposure, and the combination selected shall be indicated prior to initiation of the fluoroscopic exposure.

c. Means shall be provided to clearly indicate to the user whether a displayed image is the LIH radiograph or fluoroscopy. Display of the LIH radiograph shall be replaced by the fluoroscopic image concurrently with re-initiation of fluoroscopic exposure, unless separate displays are provided for the LIH radiograph and fluoroscopic images.

10. Displays of Values of AKR and Cumulative Air Kerma. Fluoroscopic equipment manufactured on or after June 10, 2006, shall display at the fluoroscopist's working position the AKR and cumulative air kerma. The following requirements apply for each X-ray tube used during an examination or procedure.

a. When the X-ray tube is activated and the number of images produced per unit time is greater than six images per second, the AKR in mGy/min shall be continuously displayed and updated at least once every second.

b. The cumulative air kerma in units of mGy shall be displayed either within five seconds of termination of an exposure or displayed continuously and updated at least once every five seconds.

c. The display of the AKR shall be clearly distinguishable from the display of the cumulative air kerma.

d. The AKR and cumulative air kerma shall represent the value for conditions of free-in-air irradiation at one of the following reference locations specified according to the type of fluoroscope.

i. For fluoroscopes with X-ray source below the X-ray table, X-ray source above the table, or of lateral type, the reference location shall be the respective locations specified in LAC 33:XV.605.A.4.d.i, ii, or v for measuring compliance with AKR limits.

ii. For C-arm fluoroscopes, the reference location shall be 15 cm from the isocenter toward the X-ray source along the beam axis. Alternatively, the reference location shall be at a point specified by the manufacturer to represent the location of the intersection of the X-ray beam with the patient's skin.

e. Means shall be provided to reset to zero the display of cumulative air kerma prior to the commencement of a new examination or procedure.

f. The displayed AKR and cumulative air kerma shall not deviate from the actual values by more than +/- 35 percent over the range of 6 mGy/min and 100 mGy to the maximum indication of AKR and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than three seconds.

11. Protection from Scattered Radiation

a. For stationary fluoroscopic systems, ancillary shielding, such as drapes, self-supporting curtains, or viewing shields, shall be available and used as supplemental protection for all individuals other than the patient in the room during a fluoroscopy procedure.

b. Where sterile fields or special procedures prohibit the use of normal protective barriers or drapes, all of the following conditions shall be met.

i. Shielding required under LAC 33:XV.605.A.11.a shall be maintained to the degree possible under the clinical conditions.

ii. All persons, except the patient, in the room where fluoroscopy is performed shall wear protective aprons that provide a lead equivalent shielding of at least 0.25 mm.

iii. The fluoroscopic field size shall be reduced to the minimum required for the procedure being performed (area of clinical interest).

iv. Operating and safety procedures shall reflect the above conditions, and fluoroscopy personnel shall exhibit awareness of situations requiring the use and/or nonuse of the protective drapes.

12. Radiation Therapy Simulation Systems. Radiation therapy simulation systems shall be exempt from all the requirements of LAC 33:XV.605.A.1, 4, 5, and 8, provided that:

a. such systems are designed and used in such a manner that no individual other than the patient is in the X-ray room during periods when the system is producing X-rays; and

b. systems that do not meet the requirements of LAC 33:XV.605.A.8 are provided with a means of indicating the cumulative time that an individual patient has been exposed to X-rays. Procedures shall require in such cases that the timer be reset between examinations.

B. Operator Qualifications

1. In addition to the applicable sections of these regulations, the operation of a fluoroscopic X-ray system for clinical purposes shall be limited to:

a. a licensed practitioner or medical resident working within his or her scope of practice;

b. an individual who has passed the American Registry of Radiologic Technologists (ARRT) Fluoroscopy Exam (or equivalent) and holds a valid certification, and only under the general supervision of the licensed practitioner meeting the conditions in LAC 33:XV.605.B.1.a; or

c. a radiologic technologist not meeting LAC 33:XV.605.B.1.b, or a radiologic technology student, in training, and only under the personal supervision of the licensed practitioner meeting the conditions of LAC 33:XV.605.B.1.a.

2. All persons operating, or supervising the operation of, fluoroscopy systems shall have completed a minimum of two hours of training that includes but is not limited to the following:

a. basic properties of radiation;

b. biological effects of X-ray;

c. radiation protection methods for patients and staff;

d. units of measurement and dose, including dosearea product (DAP) values and air kerma;

e. factors affecting fluoroscopic outputs;

f. high level control options;

g. dose management including dose reduction techniques, monitoring, and recording;

h. principles and operation of the specific fluoroscopic X-ray system(s) to be used;

i. fluoroscopic and fluorographic outputs of each mode of operation on the system(s) to be used clinically; and

j. applicable requirements of these regulations.

3. Documentation pertaining to the requirements of LAC 33:XV.605 shall be maintained for review by the department for three years.

C. Equipment Operation

1. All fluoroscopic images shall be viewed, directly or indirectly, and interpreted by a licensed practitioner of the healing arts.

2. Overhead fluoroscopy shall not be used as a positioning tool for general purpose radiographic examinations.

3. Operators shall be competent in the standard operating procedures of the unit in use, including the use of available dose-saving features, and the relative radiation output rates of the various modes of operation.

4. Procedure planning for fluoroscopic procedures on pregnant patients shall include feasible modifications to minimize dose to the conceptus.

5. Procedure planning for fluoroscopic procedures on pediatric patients shall include feasible modifications to minimize dose.

6. The registrant shall use all methods available on the fluoroscopy system to monitor dose during a fluoroscopic procedure.

7. The facility shall establish a written policy regarding patient dose management in fluoroscopically guided procedures.

D. Qualified Expert (QE) Evaluations

1. Fluoroscopic equipment shall be evaluated by a QE within 30 days of installation and of any maintenance of the system that may affect the exposure rate. Thereafter, the measurements shall be made at intervals of no less than 12 months, and no more than 14 months, from the date of the prior measurement by or under the direction of a QE. At a minimum, these evaluations shall include:

a. a measurement of entrance exposure rates that covers the full range of patient thicknesses including those that are expected to drive the system to maximum output in normal mode. In addition, a single representative measurement of maximum output in all other available modes clinically used must be performed. These measurements shall:

i. for systems without automatic exposure control, be made utilizing a milliamperage and kVp typical of the clinical use of the fluoroscopic system;

ii. for systems with automatic exposure control, be made utilizing sufficient attenuating material in the useful beam to produce a milliamperage and kVp typical of the clinical use of the fluoroscopic system;

b. a measurement and verification of compliance of maximum AKR for fluoroscopy and high-level control, if available. Measurements shall be made in accordance with LAC 33:XV.605.A.4.d;

c. an evaluation of high contrast resolution and low contrast resolution in both fluoroscopic and spot-film modes;

d. an evaluation of the operation of the five-minute timer, warning lights, interlocks, and collision sensors;

e. an evaluation of the beam quality;

f. an evaluation of collimation in the fluoroscopy and spot-film modes;

g. an evaluation of the availability and accuracy of technique indicators and integrated radiation dose displays; and

h. an evaluation of any changes that may impact patient and personnel protection devices.

2. Measurements required in LAC 33:XV.605.D.1 shall be performed with a calibrated dosimetry system per manufacturer recommendations not to exceed two years and records maintained for five years for inspection by the department.

E. Additional requirements for facilities performing fluoroscopically-guided interventional (FGI) procedures are as follows:

1. provide an annual report to the radiation safety committee or the person responsible for radiation safety, in the absence of a radiation safety committee;

2. establish and implement FGI procedure protocols as follows:

a. the registrant shall establish and implement written protocols, or protocols documented in an electronic report system, that include but are not limited to the following:

i. identification of individuals who are authorized to use fluoroscopic systems for interventional purposes;

ii. a method to be used to monitor patient radiation dose during FGI;

iii. dose notification levels, as appropriate, at which the physician is notified and appropriate actions are taken for patient safety; and

iv. a review of the established protocols at intervals of no less than 12 months, and no more than 14 months, from the previous review;

b. a record of each protocol shall be maintained for inspection by the department. If the registrant revises a protocol, documentation shall be maintained that includes the justification for the revision and the previous protocol for inspection by the department;

3. develop procedures for maintaining records as follows:

a. a record of radiation output information shall be maintained in an area where any fluoroscopist shall have ready access to such results while using the fluoroscope so the radiation dose to the skin may be estimated in accordance with established protocols. The record shall include the following:

i. patient identification;

ii. type and date of examination;

iii. identification of the fluoroscopic system used;

iv. peak skin dose, cumulative air kerma, or dose area product used if the information is available on the fluoroscopic system; and

v. if the peak skin dose, cumulative air kerma, or dose area product are not displayed on the fluoroscopic system, records shall include other information necessary to estimate the radiation dose to the skin in accordance with established protocol or the following, as necessary:

(a). fluoroscopic mode, such as, high-level or pulsed mode of operation;

(b). cumulative fluoroscopic exposure time; and

(c). number of films or recorded exposures;

b. the registrant shall maintain records required by this Paragraph for inspection by the department.

La. Admin. Code tit. 33, § XV-605

Promulgated by the Department of Environmental Quality, Nuclear Energy Division, LR 13:569 (October 1987), amended by the Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 19:1421 (November 1993), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 26:2270 (October 2000), LR 26:2586 (November 2000), LR 28:1952 (September 2002), Amended by the Office of the Secretary, Legal Affairs and Criminal Investigations Division, LR 482935 (12/1/2022).

AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 et seq. and 2104.B.